Active Pharmaceutical Ingredient

Pyrilamine Maleate — CAS 59-33-6

Also known as: Mepyramine Maleate; Neo-Antergan Maleate

GMP Certified IP / BP / EP / USP First-Generation Antihistamine (H1 Receptor Antagonist) Aurangabad, India
Pyrilamine Maleate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pyrilamine Maleate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 59-33-6

Product Overview

Pyrilamine Maleate (Mepyramine Maleate) is a first-generation H1 antihistamine with sedative properties. Manufactured by Mediocon Inc at its GMP-certified facility in Aurangabad, Maharashtra, India, it is supplied for oral antihistamine formulations and combination cold/allergy products. CAS No: 59-33-6.

Therapeutic Applications
  • Relief of symptoms of hay fever, urticaria, and allergic rhinitis
  • Combination cold and flu formulations
  • Premenstrual syndrome (PMS) products as sleep aid
  • Topical antihistamine formulations for insect bites and rashes

Technical Specifications

ParameterSpecification
CAS Number59-33-6
Molecular FormulaC17H23N3O·C4H4O4
Molecular Weight401.46 g/mol
GradeIP / BP / EP / USP
CategoryFirst-Generation Antihistamine (H1 Receptor Antagonist)
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water and ethanol.
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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